Drybench Patent.
BEROTRALSTAT DIHYDROCHLORIDE, NDA 214094
The patents and exclusivities FDA's Orange Book lists for NDA 214094 as captured on 14 October 2026, each date named by its rule and its rows, and the rows of FDA's Paragraph IV list that give this NDA's number, as captured on 17 October 2026. Listed protection is a range of dates, never one date.
FDA capture · review pending. Each row is shown as captured from FDA's Orange Book files and Paragraph IV list. Dates are FDA's own; spreadsheet day numbers are shown as dates, and a cell that cannot be read as one date is shown as written and left out of the range. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. A Paragraph IV row is placed here only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.
- Orange Book captured
- 14 October 2026
- Paragraph IV list captured
- 17 October 2026
- Last checked
- 30 October 2026
- Data-branch commit
- dadcab56563716abea6c5e31a5e1970080c778ef
Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.
Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.
Open in the appBEROTRALSTAT DIHYDROCHLORIDE in the molecule app
Listed protection
Listed dates run from 3 Dec 2027 to 1 May 2040, each by its own rule; no one date stands for this product.
- Earliest listed date
- 3 Dec 2027ODE-333 exclusivityRule R3 · Products 001, 002 · exclusivity.txt lines 1,298, 1,300
- Latest listed date
- 1 May 2040US 12,590,069 with pediatric exclusivity, as listedRule R2 · Products 001, 002 · patent.txt lines 15,493, 15,525
- Latest substance patent
- 1 May 2040US 12,590,069 with pediatric exclusivity, as listedRule R2 · Products 001, 002 · patent.txt lines 15,493, 15,525
- Latest listed patent
- 1 May 2040US 12,590,069 with pediatric exclusivity, as listedRule R2 · Products 001, 002 · patent.txt lines 15,493, 15,525
- Latest exclusivity
- 3 Jun 2028PED exclusivityRule R3 · Products 001, 002 · exclusivity.txt lines 1,299, 1,301
16 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 214094, as listed. The sections below name products by these numbers.
Product 001 · ORLADEYO
- Dosage form; route
- CAPSULE;ORAL
- Strength
- EQ 110MG BASE
- Approval date as listed
- 3 Dec 2020
- Type as listed
- RX
- Applicant as listed
- BIOCRYST PHARMACEUTICALS INC
Product 002 · ORLADEYO
- Dosage form; route
- CAPSULE;ORAL
- Strength
- EQ 150MG BASE
- Approval date as listed
- 3 Dec 2020
- Type as listed
- RX
- Applicant as listed
- BIOCRYST PHARMACEUTICALS INC
Listed patents
Every patent the FDA lists for this product, as the application holder submitted it, with its flags. The FDA does not verify listings.
32 entries from 64 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 10,329,260, substance patent
patent.txt lines 15,466, 15,498- Expiry as listed
- 9 Mar 2035
- Rule
- R1
- Flags
- substance
- Product numbers
- 001, 002
US 10,689,346, use patent
patent.txt lines 15,470, 15,502- Expiry as listed
- 9 Mar 2035
- Rule
- R1
- Flags
- use code U-3010
- Product numbers
- 001, 002
US 11,230,530, use patent
patent.txt lines 15,474, 15,506- Expiry as listed
- 9 Mar 2035
- Rule
- R1
- Flags
- use code U-3300
- Product numbers
- 001, 002
US 11,708,333, use patent
patent.txt lines 15,478, 15,510- Expiry as listed
- 9 Mar 2035
- Rule
- R1
- Flags
- use code U-3300
- Product numbers
- 001, 002
US 12,116,346, substance patent
patent.txt lines 15,480, 15,512- Expiry as listed
- 9 Mar 2035
- Rule
- R1
- Flags
- substance
- Product numbers
- 001, 002
US 10,125,102, substance and use patent
patent.txt lines 15,464, 15,496- Expiry as listed
- 7 Apr 2035
- Rule
- R1
- Flags
- substance · use code U-3010
- Product numbers
- 001, 002
US 10,329,260 with pediatric exclusivity, as listed
patent.txt lines 15,465, 15,497- Expiry as listed
- 9 Sep 2035
- Rule
- R2
- Flags
- substance · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 10,689,346 with pediatric exclusivity, as listed
patent.txt lines 15,469, 15,501- Expiry as listed
- 9 Sep 2035
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 11,230,530 with pediatric exclusivity, as listed
patent.txt lines 15,473, 15,505- Expiry as listed
- 9 Sep 2035
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 11,708,333 with pediatric exclusivity, as listed
patent.txt lines 15,477, 15,509- Expiry as listed
- 9 Sep 2035
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 12,116,346 with pediatric exclusivity, as listed
patent.txt lines 15,479, 15,511- Expiry as listed
- 9 Sep 2035
- Rule
- R2
- Flags
- substance · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 10,125,102 with pediatric exclusivity, as listed
patent.txt lines 15,463, 15,495- Expiry as listed
- 7 Oct 2035
- Rule
- R2
- Flags
- substance · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 10,662,160, substance and use patent
patent.txt lines 15,468, 15,500- Expiry as listed
- 1 Nov 2039
- Rule
- R1
- Flags
- substance · use code U-3010
- Product numbers
- 001, 002
US 11,117,867, product and use patent
patent.txt lines 15,472, 15,504- Expiry as listed
- 1 Nov 2039
- Rule
- R1
- Flags
- product · use code U-3010
- Product numbers
- 001, 002
US 11,618,733, use patent
patent.txt lines 15,476, 15,508- Expiry as listed
- 1 Nov 2039
- Rule
- R1
- Flags
- use code U-3300
- Product numbers
- 001, 002
US 12,344,585, use patent
patent.txt lines 15,482, 15,514- Expiry as listed
- 1 Nov 2039
- Rule
- R1
- Flags
- use code U-3010
- Product numbers
- 001, 002
US 12,545,645, substance and product patent
patent.txt lines 15,484, 15,516- Expiry as listed
- 1 Nov 2039
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 12,545,646, substance and product patent
patent.txt lines 15,486, 15,518- Expiry as listed
- 1 Nov 2039
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 12,545,647, substance and product patent
patent.txt lines 15,488, 15,520- Expiry as listed
- 1 Nov 2039
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 12,552,750, substance and product patent
patent.txt lines 15,490, 15,522- Expiry as listed
- 1 Nov 2039
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 12,590,068, substance and product patent
patent.txt lines 15,492, 15,524- Expiry as listed
- 1 Nov 2039
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 12,590,069, substance and product patent
patent.txt lines 15,494, 15,526- Expiry as listed
- 1 Nov 2039
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 10,662,160 with pediatric exclusivity, as listed
patent.txt lines 15,467, 15,499- Expiry as listed
- 1 May 2040
- Rule
- R2
- Flags
- substance · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 11,117,867 with pediatric exclusivity, as listed
patent.txt lines 15,471, 15,503- Expiry as listed
- 1 May 2040
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 11,618,733 with pediatric exclusivity, as listed
patent.txt lines 15,475, 15,507- Expiry as listed
- 1 May 2040
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 12,344,585 with pediatric exclusivity, as listed
patent.txt lines 15,481, 15,513- Expiry as listed
- 1 May 2040
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 12,545,645 with pediatric exclusivity, as listed
patent.txt lines 15,483, 15,515- Expiry as listed
- 1 May 2040
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 12,545,646 with pediatric exclusivity, as listed
patent.txt lines 15,485, 15,517- Expiry as listed
- 1 May 2040
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 12,545,647 with pediatric exclusivity, as listed
patent.txt lines 15,487, 15,519- Expiry as listed
- 1 May 2040
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 12,552,750 with pediatric exclusivity, as listed
patent.txt lines 15,489, 15,521- Expiry as listed
- 1 May 2040
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 12,590,068 with pediatric exclusivity, as listed
patent.txt lines 15,491, 15,523- Expiry as listed
- 1 May 2040
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 12,590,069 with pediatric exclusivity, as listed
patent.txt lines 15,493, 15,525- Expiry as listed
- 1 May 2040
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
Listed exclusivities
Each exclusivity FDA lists for NDA 214094, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
ODE-333 exclusivity
exclusivity.txt lines 1,298, 1,300- Date
- 3 Dec 2027
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
PED exclusivity
exclusivity.txt lines 1,299, 1,301- Date
- 3 Jun 2028
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
Paragraph IV list rows giving NDA 214094
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 214094, each cell as listed.
FDA's Paragraph IV list names no patent number, so it does not say which of the patents on this page an applicant certified against.
The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.
Rows whose RLD/NDA cell we could not read as exactly one NDA number are kept apart on the list page; some may concern this product.
Rows on FDA's Paragraph IV list whose RLD/NDA cell gives NDA 214094
Berotralstat Hydrochloride · Capsules · 110 mg and 150 mg
RLD/NDA as listed: Orladeyo 214094- First PIV submission
- 3 Dec 2024
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 1 Nov 2039
Notes from the trace
- R6 tentative approvals: not in the Orange Book data files as captured; the Drugs@FDA join is a later ruling.
Patents vs FDA exclusivityHow to read the Orange Book data filesParagraph IV certificationWhat changed, by week